A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)

A Phase Ib/IIa Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerance, Pharmacokinetics/ Pharmacodynamics(PK/PD) of ICP-022 in Patients With Mild and Moderate Systemic Lupus Erythematosus

The purpose of the study is to assess the Safety, Tolerability, PK/PD and preliminary Efficacy of ICP-022 in Subjects with Systemic Lupus Erythematosus (SLE)

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: ICP-022; Drug: ICP-022; Drug: ICP-022; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • The First Affiliated Hospital of Bengbu Medical College
  • Beijing
    • Beijing, Beijing, China, 100000
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100000
      • Peking University People's Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangdong General Hospital
    • Shenzhen, Guangdong, China
      • ShenZhen People's Hospital
    • Shenzhen, Guangdong, China
      • University of Hong Kong Shenzhen Hospital
  • Henan
    • Zhengzhou, Henan, China
      • First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Gulou Hospital Affiliated to Medical College of Nanjing University
  • Shanghai
    • Shanghai, Shanghai, China
      • Huashan Hospital affiliated to Fudan University
  • Shanxi
    • Taiyuan, Shanxi, China
      • The First Affiliated Hospital of Shanxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female subjects aged 18 to 75
2. diagnosis of with SLE at least 6 months at screening visit
3. SLEDAE-2K≥5
4. Is receiving standard treatment for SLE and has been receiving treatment for at least 3 months.
5. At least one SLE activity manifestation (as assessed by SLEDAE-2K)

Exclusion Criteria:

1. Failure to comply with the requirements of the programme
2. A female or male partner who is pregnant or breastfeeding or who plans to become pregnant during the study period
3. Previously treated with a BTK inhibitor
4. Neuropsychiatric lupus (NPSLE)
5. Has other autoimmune diseases other than SLE

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebos; Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Experimental: Medium Dose	Drug: ICP-022; Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period; Other Names: Orelabrutinib; Drug: ICP-022; Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period; Other Names: Orelabrutinib; Drug: ICP-022; Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period; Other Names: Orelabrutinib
Experimental: Lower Dose	Drug: ICP-022; Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period; Other Names: Orelabrutinib; Drug: ICP-022; Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period; Other Names: Orelabrutinib; Drug: ICP-022; Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period; Other Names: Orelabrutinib
Experimental: Higher Dose	Drug: ICP-022; Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period; Other Names: Orelabrutinib; Drug: ICP-022; Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period; Other Names: Orelabrutinib; Drug: ICP-022; Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period; Other Names: Orelabrutinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to 28 Days after the last dose of study drug
Number of Patients with Treatment-emergent Adverse Event(TEAEs) according to severity	Up to 28 Days after the last dose of study drug
Number of participants with clinically significant physical examination abnormalities	Up to 28 Days after the last dose of study drug
Number of participants with clinically significant vital signs abnormalities	Up to 28 Days after the last dose of study drug
Number of participants with clinically significant ECG abnormalities	Up to 28 Days after the last dose of study drug
Number of participants with clinically significant laboratory examination abnormalities	Up to 28 Days after the last dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4)		12 Weeks
Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6)		12 Weeks
Occupancy rate of Bruton Tyrosine Kinase(BTK)		14 Days
Serum Immunoglobulin (Ig) level		12 Weeks
Changes from Baseline in Ig levels		12 Weeks
Changes from Baseline in C3		12 Weeks
Changes from Baseline in C4		12 Weeks
Changes from Baseline in serum dsDNA		12 Weeks
Changes from Baseline in Anti-nuclear Antibodies		12 Weeks
Changes from Baseline in Interferon-α(INF-α) level	Changes from Baseline in cytokine levels	12 Weeks
Changes from Baseline in Interleukin-6(IL-6) level	Changes from Baseline in cytokine levels	12 Weeks
Changes from Baseline in total B cell counts		12 Weeks
Change from Baseline in Beffs count		12 Weeks
Changes from baseline in Bregs count		12 Weeks
Changes from Baseline in Bregs to Beffs ratio		12 Weeks
Changes from Baseline in Erythrocyte Sedimentation Rate(ESR)		12 Weeks
The plasma concentration-time curve		14 Days

Collaborators and Investigators

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
• Investigators: Principal Investigator: Zhanguo Li, MD/PhD, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Actual): April 28, 2022
• Study Completion (Actual): April 28, 2022

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 10, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Mild to Moderate
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: ICP-CL-00109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No